Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

Sponsor
King's College Hospital NHS Trust
Study ID
NCT01030770
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Diabetes Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls).
  • 0.9% Sodium Chloride — DRUG
    Single subconjunctival injection of 0.05mls of 0.9% w/v sodium chloride

Study Details

This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease). It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.

Key Dates

First listed
Dec 11, 2009
Start date
Jul 31, 2010
Status verified
Dec 2016
Primary completion
Dec 31, 2015
Completion
May 31, 2016

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (treatment)
    Arm A: Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls) (Lucentis®)
  • Placebo Comparator: Arm B (control):
    Arm B: Single subconjunctival injection of 0.05mls of 0.9% sodium chloride (Minims Saline®)

Primary Outcome Measure

Number of patients requiring pars plana vitrectomy at week 7. [ Time Frame: 12 months ]

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